A Comparison of Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery: A Prospective Randomized Study

STU 092016-061

Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.

2017-05-08

2022-08-18

2023-04-04

Terminated

Early phase I

46

Inclusion Criteria: * Adult subjects aged 18 years or older * Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels Exclusion Criteria: * Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators. * Immunocompromised subject * Coagulopathy * Severe liver and renal dysfunction * Preoperative neurological deficits * The dura damage during surgery * Inability to follow directions or comprehend the English language. * Females who are pregnant as determined by positive pregnancy test on or before the day of surgery. * Prisoners. * Patient refusal to provide informed consent. * Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) or opioid (fentanyl) allergy if patient assigned epidural analgesia. * Hydromorphone allergy if patient assigned IV PCA

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}

2023-10-26